FDA product code · Hematology

Test, Thrombin Time

Name: FDA decisions, review times, recalls and adverse event reports for product code GJA
Creator: 510(k) Report

GJAClass II21 CFR 864.7875510(k) required20 decisions since 19794 recalls

20 FDA decisions since 1979. 4 recalls name this code, 0 of them Class I. The most-cited predicate is K884384, named by 1 later device.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, hematology panel

Twenty years of GJA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · GJA

FDA has decided no GJA device since 2007.

Median 510(k) review, days · GJA

Too few GJA 510(k)s in any year since 2007 to give a median.

Recalls per year · GJA

1in 2017

2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GJA

2in 2023

2007high 10 (2017) · low 0 (2007)2025

MAUDE reports naming product code GJA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	2
2013	—	0	0
2014	—	0	0
2015	—	0	1
2016	—	0	0
2017	—	1	10
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	2
2024	—	0	0
2025	—	0	0
2026	—	0	—

FIG. 1 — GJA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GJA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 864.7875.

GJB Thrombin

Test, Thrombin Time

Which predicates do GJA devices cite most?

Which GJA devices have the deepest lineage?

What has FDA decided in GJA lately?

What has been recalled in GJA lately?

Related product codes